Adjustable fixation device

ABSTRACT

An articulated fixation device is provided having a high degree of adjustability for securing a plate member thereof to a skull and at least one spinal rod thereof to a vertebral bone. In one form, an adjustable bridge member is provided that is adjustably connected to both the plate member and the spinal rod. The adjustable connections can include an upper and rearward pivot connection between the plate member and the bridge member and a lower and forward pivot connection between the spinal rod and the bridge member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/119,946, filed Aug. 31, 2018, which is a continuation of U.S. patentapplication Ser. No. 14/974,843, filed Dec. 18, 2015, now U.S. Pat. No.10,064,661, which is a continuation of U.S. patent application Ser. No.13/710,058, filed Dec. 10, 2012, now U.S. Pat. No. 9,216,042, whichclaims the benefit of U.S. Provisional Application No. 61/569,064entitled “Adjustable Occipital Plate Device” filed Dec. 9, 2011, whichare all hereby incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention relates generally to devices for securing the ends ofspinal rods or other elongate fixation members to the skull of a patientfor spinal repair and/or fusion surgeries.

BACKGROUND OF THE INVENTION

Rigid or semi-rigid elongate members, such as spinal rods, may bemounted to the spinal column in order to stabilize or immobilizevertebrae of the spinal column for a variety of purposes. For instance,spinal rods are often secured to adjacent vertebral bodies via anchormembers in order to promote fusion of the two vertebrae as a treatmentfor degenerative disc disease, spondylolisthesis, spinal stenosis,fractures of the vertebrae, and other conditions. Limiting or preventingmotion of the vertebrae promotes the healing process. By removal of thedisc positioned between the vertebrae and limiting motion between thevertebrae, the adjacent boney surfaces are allowed to grow into oneanother and fuse together. Fusion devices may also be placed between thetwo immobilized vertebrae in order to facilitate the process of fusion.

When stabilizing portions of the spinal column, and in particular thecervical region of the spine, it is sometimes necessary to immobilizethe skull in addition to vertebrae. The same elongate rigid structuresused to link and stabilize the vertebrae may therefore be secured to theskull in order to keep the skull in an appropriate spatial relationshipwith respect to the spinal column. However, since the anatomy andthickness of the skull and its surrounding tissues are very differentthan those of the vertebrae and their surrounding tissues, the elongaterigid structures must be anchored to the skull in a different mannerthan that used for the vertebrae.

For instance, in many spinal stabilization procedures elongate rods madeof titanium or other materials are placed adjacent to the posterior sideof the spine and anchored in place using screws connected to some typeof coupling assembly. Examples of coupling assemblies for posteriorfixation systems are disclosed in U.S. Pat. No. 7,141,051; U.S.Published Application No. 2008/0045955; and U.S. Published ApplicationNo. 2007/0225711. The screws used to anchor these devices and othercoupling assemblies are often relatively long, and are mounted to thepedicle area of the vertebrae with the shanks of the screws penetratingdeep into the vertebral body. The yoke portion or receiving member ofthe coupling assembly that is coupled to the screw and receives thespinal rod is nested between outwardly-extending boney processes so thatthe height of the yoke is not noticeable.

When spinal rods are mounted to the skull, however, it is undesirable touse long screws and large coupling assemblies. Many coupling assembliesalso would prove unduly cumbersome if mounted directly to the skull, andmay even protrude significantly from the back of the head. In addition,the occipital region, which juts out at the base of the skull, typicallyis the site at which to mount an internal fixation system, requiringthat spinal rods connected thereto be severely bent in order to bepositioned along the occipital region and be connected to the occipitalregion in a manner similar to the connection to the vertebrae.

Previous systems for coupling spinal rods and other elongatestabilization devices to the skull vary. However, most systems utilize aplate mounted to the occipital region of the skull that attaches to arod, cable, wire, plate, or screw mounted to a region of the spine. Inmost spinal rod systems, two spinal rods are positioned generallyparallel to the surface of the plate and then secured thereto by abracket, yoke, or other receiving member, such as a U-shaped receivingmember. The plates are mounted to the skull with several small screwsdisposed along the full length and width of the plate. Since the base ofthe skull angles inward toward the spine, the plates mounted to theskull are not parallel to the posterior surfaces of the vertebrae, andthe spinal rods must be bent significantly away from the vertebrae inorder to reach the occipital region in an orientation so that they maybe mounted to the plate. For instance, the bending of spinal rods inorder for them to properly be received relative to an occipital plate isshown in the devices of FIGS. 1, 2, and 18 of U.S. Published ApplicationNo. 2004/0153070. In that device, spinal rods mounted along thevertebrae must be manipulated in order to fit precisely into receivingmechanisms aligned along the sides of a plate designed to be fixed tothe occipital region of the skull. This bending of the rod can fatiguethe rod material, and also makes it difficult to reposition the elementsof the stabilization system.

Even attempts to provide occipital plate devices with adjustability inorder to accommodate spinal rods of various orientations still generallyrequire significant manipulation and bending of spinal rods before theycan be secured to the plate structure. For instance, U.S. Pat. No.6,902,565 discloses a plate designed to be mounted to the occipitalregion of the skull by a plurality of short expansion head screws. Theplate receives a pair of rods that may be further mounted to one or morevertebrae. In many cases these rods are pre-bent so that the majority ofthe rods may be positioned parallel to the spine, with the ends benttransversely in order to be secured to the plate by a clamp plate orbracket. Some embodiments include plates that are bent in order toreceive the rods that are parallel to the spine.

U.S. Published Application No. 2008/0051783 discloses a plate devicehaving a pair of u-shaped rod receiving members that protrude fromlateral wings of the plate. The wings may be shifted laterally andmedially, and the rod receiving members may rotate to adjust thedirection in which a connecting member (such as a spinal rod) isreceived. The spinal rods must be positioned so that they are generallyparallel to the plate surface in order to fit into the rod receivingmembers. Therefore, the ends of the rod must be bent away from the axisof the spine, which is not parallel to the plate surface, and into theu-shaped channels of the receiving members.

U.S. Pat. No. 6,524,315 discloses a plate secured to the bone by aplurality of screws. The plate is fitted with slotted bolts designed forreceiving a rod or cable. The base of the slotted bolt is recessed inthe plate at its base. A support platform may be fitted over the bolt tohelp hold the rod or cable. A nut fastens over the threaded end of theslotted bolt to trap the rod or cable within the bolt, securing it tothe plate. The bolt may be rotated to adjust the direction of the rod orcable.

U.S. Published Application 2007/0233119 discloses a plate device withpolyaxial connector head assemblies including a connector body thatreceives a spinal rod and a connector head pivotably connected to theconnector body and configured to be secured to the plate so that theconnector assemblies provide limited polyaxial movement of the spinalrods with respect to the plate. However, the coupling heads arerelatively bulky and still hold the spinal rods relatively parallel tothe plate surface.

Even more adjustable occipital plates have various shortcomings. In U.S.Published Application 2007/0118121, a fixation plate includes alaterally extending arm coupled to a pair of spinal rods by slidinglinks that are able to slide along and pivot about the arms. However,ends of the spinal rods are held relatively close to the fixation plate,and positioning of the sliding links is limited to sliding and pivotingalong the fixed laterally extending arms. Further, the sliding links arelocked in place by clamping together top and bottom portions thereofwith a set screw positioned at a distance from the laterally extendingarm, which compresses a rounded portion of the link about the arm inorder to inhibit sliding. However, the locking force between the slidinglinks and the laterally extending arms may not be able to preventpivoting or sliding of the spinal rods relative to the fixation platewhen sufficient force is applied.

U.S. Pat. No. 7,901,433 also discloses an adjustable occipital platesystem that permits spinal rods to be positioned at various angles withrespect to the plane of the occipital plate. The horseshoe-shaped platehas a lateral arm extending from each side, with a variable connectorsecuring each spinal rod to a lateral arm of the plate system. A gapseparates the two lateral arms, and may allow some twisting of the platearms and spinal rods. In addition, the horseshoe-shape of the plate maynot allow all of the bone screws to be driven into the thickest andhardest bone which is typically in the central area of the occipitalregion of the skull. The horseshoe-plate of the '433 patent also willhave to be bent because of its substantially flat configuration and thenon-flat or curved configuration of the skull's occipital region.Bending of the relatively narrow, curved arms of the plate willundesirably further weaken the plate. Additionally, bending the plateand the rods involves trial-and-error and, as such, is typically a verytime consuming process. This is particularly challenging with thesetypes of occipital plate and spinal rod assembles where during surgery,the patient's occiput and cervical vertebrae are typically oriented oneway relative to each other with the patient supported on an operatingtable, and need to be oriented another way relative to each other forfinal fixation of the assembly to the occiput and the cervicalvertebrae. The connectors of the '433 patent hold the spinal rods belowor even with the lateral arms, and thus relatively close to the spine.However, this can create interference with the cervical vertebraeimmediately below the occiput (i.e., the C1 and C2 vertebrae), andpotentially the brain stem where it may be exposed due to damage tosurrounding bone.

SUMMARY OF THE INVENTION

Fixation devices are provided herein for mounting to bone and receivingone or more spinal rods. The devices may offer the ability to receivespinal rods in various orientations without requiring significantbending, if any, of the spinal rods. For instance, the devices may allowfor adjustment of the angle of the rod or other connecting member withrespect to the surface of the occipital plate device, and may allowmultiple types of movement and adjustability for a highly articulateddevice. Typically, these systems include a plate member that is curvedto generally conform to the surface of the skull and particularly theoccipital region or occiput thereof, or another boney region. Thefixation devices also have coupling devices that include couplingmembers or rod receiving members for coupling elongate connectingmembers, such as spinal rods, to the plate member, with the couplingmembers configured to have multiple degrees of adjustability in order toaccommodate elongate connecting members of various configurations andorientations relative to the plate member. The adjustable couplingdevices allow the fixation or plate device to secure spinal rods ofvarious configurations and orientations without significantly bendingthe spinal rods, thus avoiding unnecessary stress and fatigue on therods. Although the devices may be configured to secure a variety ofelongate connecting members, such as rods, cables, wires, and the like,spinal rods will be primarily discussed herein. It will be understood,however, that this description is not intended to be limiting, and thatthe invention is intended to be adapted for use with a variety ofconnecting members of different shapes, sizes, and configurations.

The plate devices disclosed herein are optimally configured to receiveand hold spinal rod members over prior art plate devices configured formounting to the occipital region of the skull, and may secure spinalrods having different orientations, configurations, and spacing withoutrequiring bending of the rods. The plate devices provided herein haveimproved adjustability and/or are more easily implanted and locked tofix the spinal rods in place when compared to the prior art. The platedevices can be adapted by a surgeon to lock spinal rods withoutsignificant bending of the rods. Prior art devices which require spinalrods to be bent to fit properly to the occipital place can fatigue therods, potentially resulting in breakage of the rod and failure of thespinal stabilization system.

In certain forms, the occipital devices described herein include arelatively flat plate member configured to be secured to a patient'socciput, and are secured to a pair of spinal rods through adjustablecoupling devices. Although the plate member is relatively flat, it neednot be planar, and preferably has a slight curvature at least along itsengagement surface with the skull to substantially match the surfacecurvature of the occipital region of the skull. The plate member mayinclude a plurality of apertures for receiving anchor members thatsecure the plate member to the skull. The plate may also be providedwith grooves or notches at particular points along its surface in orderto enhance the bendability of the plate or to allow certain portions ofthe plate to be removed if unneeded.

More particularly, in one form, the plate member has a compactconfiguration particularly in the lateral direction or generally in atransverse plane along the base of the skull. In this regard, the platemember has a main plate body portion that can have a generally polygonalconfiguration, albeit with some curvature along the perimeter thereof,so that there are no gaps in the main body portion beyond aperturestherein for fasteners to secure the plate member to the skull. One suchconfiguration can be a pentagonal configuration, for instance. With itscompact configuration, the plate member herein is able to be secured tothe central area of the occipital region where the greatest purchasewith the fasteners can be achieved in the thickest and hardest bone ofthe occiput.

In another form, the compact plate member has a plurality of aperturesfor fasteners that are generally aligned along the longitudinal axis ofthe fixation device or in a coronal plane. The longitudinally alignedapertures also assists in keeping the lateral size of the main bodyportion to a minimum. In one preferred form, the plate member alsoincludes extension portions that have apertures for fasteners, and thatcan be aligned with the longitudinally aligned apertures. The extensionportions and the main body portion have weakened or frangible portionstherebetween to allow the extension portions to be bent or removed fromthe plate member so that the size of the plate member can also beadjusted, such as in the longitudinal direction, to accommodateanatomical variations in the occipital regions of different patients.

The plate member may be coupled to a modular bridge portion or memberthat is adjustable with respect to the plate, with the adjustableconnection being generally toward the lower longitudinal end of theplate member and toward the upper longitudinal end of the bridge member.A pair of coupling devices or yoke devices may be adjustably connectedto the bridge member in order to receive spinal rods which can extend invarious directions without requiring significant bending of the spinalrods, which can cause fatigue and failure of the spinal rods. Theadjustable connections between yoke devices, and thus the spinal rods,and the bridge member is preferably generally toward the lowerlongitudinal end of the bridge member and toward the upper longitudinalends of the spinal rods. With the bridge member adjustably connected tothe plate member, and to the spinal rods via the adjustably connectedcoupling devices, the bridge member has longitudinally spaced adjustableconnections to the plate member and the spinal rods such that thefixation device has an articulated structure with adjustable connectionsthat are spaced in the longitudinal and fore-and-art directions when thedevice is implanted. In this manner, the articulated fixation device canbe secured to the occiput and the cervical vertebrae without needing tosignificantly bend the plate member and the spinal rods if at all.

If the bridge portion of the device is adjustable relative to the platemember such as via coupling devices and rod portions of the plate memberand the bridge member, the bridge member or portion may be adjusted to avariety of orientations and then locked into place at a desiredorientation. If the device includes a modular bridge portion, the platemember may be implanted before attaching the bridge portion so that thesurgeon can secure the plate to the skull without the bridge portionobstructing the process. A plurality of modular bridge members ofdifferent sizes and/or configurations also may be provided, which wouldpermit the surgeon to select different bridge portions for differentpatients or situations.

In one form, the plate member has a pair of rod-receiving bracket, yokeor receiver member portions integrated therewith at the longitudinallower corner portions thereof and laterally spaced across the platemember from each other. The yoke portions have laterally extendingchannels for receiving laterally extending rod portions of the bridgemember at the longitudinally upper end thereof. The yoke portions andthe rod portions could be reversed to be formed on the bridge member andthe plate member, respectively. Having the yoke portions formedintegrally as one-piece with the plate member, however, is advantageoussince the curved wall portions include a thickened portions of the platebody at the corner areas and curved wall portions that extend closelyadjacent thereto. In this manner, the yoke portions do not projectupwardly and in a cantilevered fashion from the bridge member andinstead the plate member maintains its robust, compact construction evenwith the yoke portions integrated therewith.

In one form, the coupling devices each are configured to receive alaterally extending rod-like portion of the bridge portion of theoccipital plate device so that each of the coupling devices may bepivoted about the rod portions so that the spinal rods can extend tovarious angles relative to the plate member, and may be shiftedlaterally along the rod-like portion. The positioning of each couplingdevice on its respective lateral arm portion may be locked by a lockingdevice, such as a set screw, that provides a locking force in order tohold a spinal rod in place within a channel of the coupling device.

The coupling devices may also be configured to receive a compressioninsert for assisting in stabilizing and locking the coupling device tothe lateral rod portions of the plate device bridge portion. Thecompression inserts may also provide a provisional hold position wheresufficient holding force is applied to the lateral arm portion tominimize accidental movement of the coupling devices, but adjustment ofthe coupling devices is still possible when sufficient force is appliedto overcome the holding force. The provisional hold provided by thecoupling device allows the main components of the articulated fixationdevice to be adjustably secured relative to the bones including thebridge member extending between the plate member and the spinal rodswith the patient supported on the operation table facing downwardly. Theprovisional hold allows for the angulation between the components to beadjusted as the occiput and cervical vertebral bones are adjusted to theposition at which they are to be fixed and also allows the components tobe exchanged for different sizes thereof before fully being locked inplace.

The bridge member can also be provided with a compact, robustconfiguration in the lateral direction where the bridge member isadjustably connected to the plate member. More particularly, thelongitudinally upper rod portion are sized to extend literally toopposite lateral ends that are laterally spaced by a smaller distancethan the corresponding opposite lateral ends of the lower rod portions.Thus, the longitudinally upper adjustable connection is maintained closeto the longitudinal axis of the device or sagittal plane where theanchoring of the plate member to the occiput is strongest.

Plate devices also may be provided with fixed bridge portions that arenot adjustable relative to the plate body. Regardless of whether thebridge portion is modular or fixed, the bridge may be arched in order toprovide clearance for avoiding contact with the vertebral processes andconnective tissue of the spine.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one form of an occipital plate deviceaccording to the present invention having a modular bridge memberadjustable and coupled to an occipital plate member and a pair of spinalrods.

FIG. 2 is a perspective view of the device from FIG. 1 from the rear,showing the engagement surface of the plate member that will be mountedto a patient's skull.

FIG. 2A is a perspective view of the device showing the curvedconfiguration of the plate member engagement surface.

FIG. 3 is an exploded view of the device of FIGS. 1 and 2 showing themodular bridge member and coupling devices separated from the platemember.

FIG. 4 is a perspective view including fragmentary portions of thecoupling devices to show the locking of the coupling devices to thebridge member and bracket portions of the plate device to the bridgemember.

FIG. 5 is a perspective view of a plate device with a fixed bridgeportion upon which adjustable coupling members are disposed.

FIG. 6 is an exploded view of the coupling members removed from thedevice shown in FIG. 5.

FIG. 7 is an exploded view of the coupling members similar to FIG. 6showing a compression insert, and a locking cap for being received in ayoke member and fixing a spinal rod relative to the plate member in theyoke member.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The plate devices disclosed herein are optimally configured to receiveand hold spinal rod members than prior art plate devices configured formounting to the occipital region of the skull, and may secure spinalrods at various positions and orientations without requiring significantbending of the rods or the plate members, if at all. The plate devicesprovided herein have improved adjustability and/or are more easilylocked to fix the spinal rods in place when compared to the prior art.

One embodiment of a device 2 including an occipital plate member withadjustable coupling devices or members for receiving spinal rods isshown in FIGS. 1-4. The illustrated device includes a relatively flatplate member 10 configured to be secured to the patient's skull andsecured to a pair of spinal rods 5 through adjustable couple couplingdevices 70. Although the plate member is relatively flat, it need not beplanar, and preferably has a slight curvature to match the surface ofthe occipital region of the skull.

As shown in FIGS. 1 and 2, the plate member 10 has a plate body 10 athat includes opposite surfaces 10 b and 10 c, and a main body portion10 d which includes a plurality of apertures 12 for receiving anchormembers that secure the plate member 10 to the skull. The surface 10 cis an engagement surface for being engaged against the skull. In thisregard, the engagement surface 10 c can have a curved, concaveconfiguration for conforming to the convexly curved occipital region ofthe skull. The main body portion 10 d has a compact configuration in thelateral direction between opposite lateral edges 10 e and 10 f so thatthe plate member 10 can be secured to the central thickness and hardestarea of the occiput. By way of example, the lateral distance between theedges 10 e and 10 f is approximately 1.025 inches. The main body portioncan have a generally polygonal configuration although the perimeteredges can include curvature thereto. Several of the apertures 12 can bealigned along the longitudinal axis 10 g so that the fasteners or bonescrews 200 are driven into the hardest and thickness central portion ofthe occiput generally along the sagittal plane. The apertures 12 mayhave tapered surfaces in order to center the anchor members disposedtherein. For instance, the rim surface 17 surrounding each aperture maybe curved or beveled in order to form a spherical or conical seatingsurface for the head of an anchor or bone screw member. The plate 10 mayalso be provided weakened or frangible portions such as in the form ofgrooves or notches 19 at particular locations such as along its surface10 b in order to enhance the bendability of the plate at those locationsin order to better match the curvature of the skull. The plate member 10may also be cut along grooves 19 to reduce the plate size if upper lobeportion 7 or lower lobe portion 9 are not needed. As illustrated, thelobe portions 7 and 19 are centrally arranged to be aligned along thelongitudinal axis 10 g along with apertures 12 formed therein.

As illustrated in FIGS. 1-4, the plate member 10 may be adjustablycoupled to a bridge portion or member 50 on which the pair of rodreceiving coupling devices or yoke devices 70 are adjustably mounted,such as by being slidably and pivotably arranged thereon. In thismanner, the device 2 is highly articulable due to adjustable connectionsprovided between the plate member 10, the intermediate bridge portion ormember 50, and the coupling devices or members 70 that receive thespinal rods 5. The spinal rods 5 can be either straight or provided witha slight curvature (FIG. 2A) to generally extend along longitudinal axis5 a. The spinal rod axis 5 a and plate axis 10 g generally extend in asagittal planes and transverse to one another. Herein, when the device 2is implanted the term longitudinal or longitudinal direction generallywill be in directions in a sagittal plane and generally along thelongitudinal axes of the main components of the articulated device 2described herein, e.g., the axes 5 a of the spinal rods 5, the axis 10 aof the plate member 10, and the axis 50 a of the bridge member 50 (seeFIG. 2a ). Accordingly, the adjustable connections of the articulateddevice 2 are longitudinally spaced and include a generallylongitudinally upper adjustable connection between the plate member 10and the bridge member 50 and a generally longitudinally lower adjustableconnection between the plate member 10 and the spinal rods 5longitudinally spaced from the upper adjustable connection generally ina sagittal plane with upper adjustable connection also being posteriorto the lower adjustable connection since plate member 10 when implantedwill also extend rearwardly from the spinal rods 5 and bridge member 50.More specifically, when the device 2 is implanted and locked in place,the upper connection is disposed above and rearwardly relative to thelower connection that is below and forwardly of the upper connection.This is because the plate member 10 is secured to the occiput at thebase of skull that projects rearwardly from the spinal column to whichthe spinal rods 5 are anchored.

The bridge member 50 shown in FIG. 1 includes a cross bar 53 havinglaterally extending end portions 53 a and 53 b that can generally berod-shaped and are adjustably held in laterally extending and upwardlyopen channels 23 of a pair of generally yoke or U-shaped rod receivingportions or mounting brackets 20 of the plate member 10 and secured inthe channels 23 by set screws 21 engagable with internal threads of themounting brackets 20. The yoke portions 20 each include diametricallyopposite curved wall portions 20 a and 20 b formed at the longitudinallower and laterally opposite corner areas of the plate body 10 a. Thewall portion 20 a is formed by a thickening of these corner areas of theplate body 10 a while the wall portion 20 extends closely adjacentthereto spaced by the channel 23 therefrom. The bridge member 50 may bepivoted about upper and rearward lateral axis 53 c defined by the rodportions 53 a and 53 b to a variety of orientations and shiftedlaterally along the axis 53 c with respect to the plate member 11 whilethe set screws 21 are positioned loosely in the mounting brackets 21,but tightening of the set screws 21 clamps the bar end portions 53 a and53 b in the brackets 21 to fix the position and orientation of thebridge member 50 with respect to the plate 11.

The bridge member 50 also includes a pair of central beams 51 and 52that join the cross bar 53 to a laterally extending portion 57 includinglaterally extending arms 55 that can generally be rod-shaped and uponwhich the adjustable coupling devices 70 are adjustably mounted.Connecting the cross bar 53 mounted to the plate 11 with the lateralportion 57 by two or more beams 51, 52 helps to resist torsion andbending of the bridge member 50 versus use of just a single beam. Thebeams 51, 52 may be further stabilized by providing one or more linkagesor brace member 56 extending laterally between and rigidly connected tothe beams 51, 52.

The coupling devices 70 associated with the bridge member 50 have outercoupling bodies or yoke members 78 that include annular wall portions 78a in which diametrically opposed through openings 71 are formed throughwhich the laterally extending arms 55 of bridge member 50 extend. Theillustrated lateral arm portions 55 are generally cylindrical orrod-shaped to allow the coupling devices to pivot, permitting them toreceive spinal rods 5 of various configurations. Shifting of thecoupling devices 70 medially and laterally along the lower lateral axis55 a defined by the laterally extending arms 55 permits the distancebetween the spinal rods 5 to be adjusted, and independent pivoting ofthe coupling devices 70 about the lateral axis 55 a their respectivelaterally extending arms 55 permits orientations of the coupling devices70 to be individually adjusted to accommodate their respective spinalrods 5. The positioning of each coupling device 70 on the arms 55 islocked by a set screw 75 that clamps the spinal rod 5 in place within anupwardly open transverse channel 73 of the coupling device 70. Thelaterally extending portion 57 may form an arch 54 between the couplingdevices 70 in order to provide clearance space 57 a for vertebralprotuberances and connective tissue of the spine between the outer arms55.

Thus, the articulated device 2 herein including the modular bridgemember 50 pivotally coupled to the plate member 10 and the spinal rods 5via the coupling devices 70 has a pair of pivot axes 53 c and 55 a thatare spaced along the sagittal plane from each other to provide thedevice 2 a high degree of adjustability between the plate member 10 andthe spinal rods 5. This high degree of adjustability is beneficial inallowing the articulated device 2 to be more readily and easily usedwith patients of varying anatomy and conditions without requiringsignificant bending of its components, if any, including the spinal rods5 and the plate member 10.

The yoke members 78 may be U-shaped members with upright arms 76 thatextend upwardly from the base portion 78 a to form the transversechannel 73 therebetween sized and configured to receive a spinal rod 5,as best seen in FIGS. 3 and 4. The upwardly open channel 73 allows thespinal rods 5 to be lowered therein. The bottom 74 of the channel 73 atthe top of one base portion 78 a between the upstanding arms 76 may becurved or rounded in order to cradle the spinal rod and provide linecontact with the rod, or may alternatively be of another shape orconfiguration. The yoke members 78 also are configured to receive alocking member such as set screws 75 that engage the upright arms 76 ofthe yoke member to secure the spinal rod 5 within the channel 73. In theillustrated embodiment, the interior surface of the upright arms 76 ofthe yoke members 78 are provided with threads 77 that interlock withcomplementary external threads of the set screw locking members 75.Alternatively, the coupling members 70 may be configured to receiveother type of locking members, such as an external nut or one of varioustypes of interior or exterior non-threaded locking members, includingbut not limited to bayonet-style locking members and the locking capsdisclosed in U.S. Pat. No. 7,141,051; U.S. Published Application No.2008/0045955; and U.S. Published Application No. 2007/0225711.

The coupling device 70 may also include a compression insert 80 forassisting in stabilizing and locking the coupling device 70 to thelaterally extending arm 55. The compression insert 80 shown in FIG. 3 isinserted through an axial bore 72 extending through the center of thecoupling device 70 and transverse, and more particularly orthogonal, tothe channel 73 for receiving the spinal rod 5. The upper surface ofcompression insert may be contoured to the surface of the spinal rod 5.In the illustrated form, the compression insert contains an upperelongate concave channel 83 configured to receive the outer cylindricalsurface of the spinal rod thereon. The illustrated compression insertalso includes claws 81 that depend from its lower surface to grip eitherside of the laterally extending arm 55 of the bridge member 50, whichcan assist in provisionally holding the coupling devices 70 in place.Then the compression insert 80 is positioned within the axial bore 72 ofthe coupling device 70, a friction fit between the insert 80 and theinterior of the coupling device 70 holds the insert 80 within the axialbore 72 of the coupling device 70. When the insert 80 is sufficientlyadvanced axially within the bore 72, it pushes against the lateral arm55 disposed within the transverse throughbore 71, providing a light orprovisional locking force to hold the position of the coupling device70. Positioning the spinal rod within the rod channel 73 and tighteningthe locking cap 75 firmly fixes the position of the coupling device 70by further pushing down on the compression insert 80, clamping thelateral arm 55 of the bridge member 50 between the lower surface portion71 a of the yoke member 88 extending about the transverse throughbore 71and the bottom surface 80 a of the compression insert 80.

In order to provide enhanced locking of the coupling device, thesurfaces of the compression insert 80, base annular well portions 78 aextending about the transverse through openings 71 therein, and/orlateral arm 55 may be keyed or contoured to better resist movement withrespect to one another when clamped. For instance, the grooved lowerarcuate surface portion 79 extending about the transverse throughbore71, the grooved lower surface 89 of the compression insert 80, and thegrooved outer surface 59 of the lateral arm 55 of the device 2 of FIG. 3interlock when the compression insert 80 clamps the lateral arm 55against the lower grooved surface portion 79 extending about thetransverse throughbore 71, causing resistance to pivoting or rotation ofthe coupling device 70 adjacent the arms 55. When the locking cap 75 isdisengaged or only lightly engaged with the spinal rod 5 extendingthrough the yoke member 78, the light lock of the compression member maystill allow some pivoting of the coupling device 70, and the groovedsurface features will provide tactile feedback to the user as thecoupling device is pivoted. When the locking cap 75 is fully advanced inthe axial bore into tight engagement with the spinal rod 5, however, thecompression insert 80 is fully advanced and clamped down against thelateral arm so that grooved surfaces 59, 79, and 89 interlock andprovide great resistance to pivoting of the coupling device 70.

The lateral arm 55, compression insert 80, and coupling device 70 may beconfigured so that when the locking cap 75 is partially tightened thecomponents are in a provisional lock or hold configuration in which onlythe grooved surface 89 of the compression insert 80 engages the grooves59 of the lateral arm 55. Further tightening of the locking cap 75causes the spinal rod 5 to push the insert 80 downwardly which, in turn,causes the arm 55 to be pushed downward for tight engagement between thecoupling device grooves 79 and the grooves 59 of the lateral arm 55. Thecoupling device may also be configured so that when the compressionmember 80 is fully advanced downward in the axial bore 72 the interiorsurface of the coupling device 70 urges or forces the claw portions 81of the insert member inward, wrapping them tightly around the lateralarm 55. The claw portions 81 also may include grooves that engage thegrooved surface 59 of the lateral arm 55.

The cross bar 53 pivotably coupled to the plate member 11 may alsoinclude surface features for enhanced locking. As shown in FIG. 3, thegrooved surface 58 of the cross bar 53 matches the grooved surface 28 ofthe bracket portions 20 of the plate member 11. When the locking devices21, for example set screws as illustrated, are engaged with the brackets20, the locking devices clamp the cross bar end portions 53 a and 53 bagainst the interior of the brackets 20. As the locking devices aretightened, for example by turning set screws so that their threadedexterior surfaces 22 engage the threaded interior 23 of the brackets 20,the grooved surface 58 of the cross bar will interlock with the arcuategrooved bottom surface 28 of the brackets 20, minimizing the potentialrotation of the cross bar 53 relative to the plate member 10 moreeffectively locking the bridge portion 50 relative to the plate member10.

Locking of the various components of the occipital plate device isfurther illustrated in FIG. 4. Prior to locking, the positioning of thebridge member 55 may be adjusted by pivoting the bridge member 55 aboutthe cross rod 53 held by the brackets 20 attached to the plate body 10.Pivoting allows a surgeon to position the bridge member 50 and couplingdevices 70 in a desired orientation relative to one another. The modularnature of the components also allows the surgeon to affix the platemember 10 to the patient's occiput bone without the bridge member 50attached, reducing interference during implantation.

After the plate member 10 is properly implanted, the cross bar 53 of thebridge member 50 may be disposed in mounting brackets 20 of the platemember and provisionally coupled thereto with the locking devices 21.The modular nature of the bridge member allows the surgeon to select oneof a plurality of bridge members that best fits a given patient. Forinstance, a kit may be provided that includes bridge members of varyinglengths, and lateral widths allowing the surgeon to implant a standardplate member 11 and then select an appropriately sized bridge member foruse with the current patient. After positioning the cross bar 53 in theplate's mounting brackets 20, the surgeon may pivot the bridge member 50in order to swing the lateral arms 55 and their respective couplingdevices closer to or farther away from the spinal column, as desired. Itis also possible to shift the entire bridge member 50 laterally betweenthe mounting brackets 20. Once all sagittal, coronal, and medial-lateraladjustments have been made and the bridge member has been properlypositioned, tightening of the locking devices 21 fixes the bridge member50 in place relative to the plate member 10.

Of course, if desired the bridge member may be attached and/or locked tothe plate member 10 prior to insertion. The coupling devices may becoupled to the spinal rods and/or locked into place with respect to thebridge member 50 before or after the position of the bridge member 50 isfixed by tightening of the locking devices 21 of the mounting brackets20. The surgeon thus has a variety of options in order to accommodatevarious patients and situations.

Another occipital plate device 110 is shown in FIGS. 5-7. As with theprevious embodiment, the device shown in FIGS. 5-7 includes a relativelyflat plate body 111 configured to be secured to the patient's skull andsecured to a pair of spinal rods through adjustable couple couplingdevices 170. The plate body 111 includes a plurality of aperturesthrough which screws 119 or other anchor members may pass in order toanchor the plate 111 to a patient's occiput. The illustrated plate alsohas grooves or notches 119 at particular points along its surface inorder to enhance the bendability of the plate at those points in orderto better match the curvature of the skull. The plate may also be cut orbroken along grooves 119 to reduce the plate size if upper lobe portion112 or lower lobe portion 114 are not needed.

Unlike the device of FIG. 1, the plate member shown in FIGS. 5-7 has afixed bridge portion 150 with integral arms 151 and 152 holding thelaterally extending portion 157 at a fixed orientation. A pair of rodreceiving coupling devices 170 are slidably and pivotably arranged onlateral arms 155 extending from the bridge portion 150. The lateral arms155 shown in FIG. 5 are positioned orthogonally to the surface of theplate body 111, so that shifting of the coupling member 170 along thelateral arms 155 changes the position of the coupling member 170 in boththe saggital plane and the coronal plane. Furthermore, pivoting of thecoupling members 170 along these orthogonal arms will cause the axes ofthe coupling members' respective rod receiving channels 173 to canttoward or away from one another instead of moving in parallel.

The coupling devices 170 associated with the device 110 shown in FIG. 5contain throughbores 171 through which the laterally extending arms 155of bridge portion 150 pass. The illustrated lateral arm portions 55 aregenerally cylindrical to allow the coupling devices to pivot. Thepositioning of each coupling device 170 is locked by a set screw 175 orother locking cap that clamps the spinal rod in place within a channel173 of the coupling device 170. The illustrated laterally extendingportion 157 forms an arch 154 between the coupling devices 170 in orderto provide clearance for vertebral protuberances and connective tissueof the spine.

The illustrated coupling members 170 of the device 110 shown in FIG. 5are U-shaped with upright arms 176 that form a channel 173 therebetweensized and shaped to receive a spinal rod. The coupling members 170 alsoare configured to receive locking members such as set screws 175 thatengage the upright arms 176 of the coupling member to secure the spinalrod within the channel 173.

As shown in FIG. 6, the coupling member 170 may also receive acompression insert 180 for assisting in stabilizing and locking thecoupling member 170 to the laterally extending arm 155. The compressioninsert shown in FIG. 6 is inserted through an axial bore 172 through thecenter of the coupling device and transverse to the rod channel 173, asbest shown in FIG. 7. The upper surface of compression insert 180 may becontoured to the surface of the spinal rod. When the insert 180 issufficiently advanced within the axial bore 172, it compresses againstthe lateral arm 155 disposed within the transverse throughbore 171,providing a light or provisional locking force to hold the position ofthe coupling device 170. Positioning the spinal rod within the rodchannel 173 and tightening the locking cap 175 firmly fixes the positionof the coupling device 170 by pushing down on the compression insert180, clamping the lateral arm 155 between the lower surface of thetransverse throughbore 171 and the bottom surface of the compressioninsert 180. The illustrated compression insert 180 includes a verticalslit 183 to allow clamp portions 182 to move together to clamp thelateral arm 155 disposed in the transverse throughbore 171 of thecoupling member 170. The clamp portions 182 are clamped together whentapered exterior camming surfaces 185 cam against tapered interiorsurfaces in the axial bore 172 of the coupling member 170.

1.-17. (canceled)
 18. A method of fixing an articulated fixation deviceto a patient, comprising: securing a plate member to the patient'sskull; selecting one of a plurality of bridge members having alongitudinal axis, wherein each of the plurality of bridge members has adifferent size or configuration for accommodating different patients;forming a first adjustable connection between the plate member and theone bridge member to allow for relative pivoting therebetween about afirst lateral pivot axis extending in the lateral direction transverseto the one bridge member longitudinal axis; forming a second adjustableconnection between the one bridge member and a rod coupling device toallow for relative pivoting therebetween about a second lateral pivotaxis extending in the lateral direction transverse to the one bridgemember longitudinal axis that is substantially parallel to the firstlateral pivot axis and longitudinally spaced therefrom.
 19. The methodof claim 18, wherein the first adjustable connection between the platemember and the one bridge member is formed prior to or subsequent tosecuring the plate member to the patient's skull.
 20. The method ofclaim 18, further comprising pivoting the one bridge member about thefirst lateral pivot axis to shift the second adjustable connection in apath transverse to the longitudinal axis and the first and secondlateral pivot axes.
 21. The method of claim 18, further comprisingfixing the plate member and the one bridge member against pivoting aboutthe first lateral pivot axis without causing fixing of the one bridgemember and the rod coupling device against pivoting about the secondlateral pivot axis.
 22. The method of claim 18, further comprisingfixing the one bridge member and the coupling device against pivotingabout the second lateral pivot axis without causing fixing of the platemember and the one bridge member against pivoting about the firstlateral pivot axis.
 23. The method of claim 18, further comprisingfixing a spinal rod to the rod coupling device and fixing the one bridgemember and the coupling device against pivoting about the second lateralpivot axis with a single locking member.
 24. The method of claim 18,further comprising adjusting the position of the one bridge memberrelative to the plate member at the first adjustable connection byshifting the one bridge member laterally along the first lateral pivotaxis.
 25. An occipito-cervical fixation system comprising: a platemember configured for being secured to a skull; a set of adjustablebridge members separate and distinct from the plate member, wherein eachadjustable bridge member of the set includes a longitudinal axis and hasa different size or configuration than the other adjustable bridgemembers for accommodating different patients; wherein the plate memberis configured to form a first adjustable connection with each adjustablebridge member in the set of separate adjustable bridge members at afirst portion of the adjustable bridge member to allow for relativepivoting between the plate member and the adjustable bridge member abouta first lateral pivot axis extending in a lateral direction transverseto the adjustable bridge member longitudinal axis; and at least one rodcoupling device configured to receive a spinal rod and to form a secondadjustable connection with each adjustable bridge member of the set ofadjustable bridge members at a second portion of the adjustable bridgemember spaced from the first portion along the longitudinal axis. 26.The occipito-cervical fixation system of claim 25, wherein the secondadjustable connection between the one adjustable bridge member secondportion and the rod coupling device is configured to allow for relativepivoting therebetween about a second lateral pivot axis extending in thelateral direction that is substantially parallel to the first lateralpivot axis and longitudinally spaced therefrom.
 27. Theoccipito-cervical fixation system of claim 25, wherein the firstadjustable connection comprises at least one yoke portion that has anintegral, one piece construction with the plate member and includes alaterally extending channel, and at least one laterally extending crossbar of the one adjustable bridge member that is configured to bepivotally received in the laterally extending channel.
 28. Theoccipito-cervical fixation system of claim 25, wherein the secondadjustable connection comprises a laterally extending through opening ofthe at least one rod coupling device that extends in a lateraldirection, and the one adjustable bridge member has a longitudinallyextending portion and a lateral arm extending laterally therefrom thatis configured to be pivotally received in the laterally extendingthrough opening.
 29. The occipito-cervical fixation system of claim 25,wherein each of the set of adjustable bridge members has a length alongthe longitudinal axis thereof different from the length of the otheradjustable bridge members.
 30. The occipito-cervical fixation system ofclaim 25, wherein each of the set of adjustable bridge members has alateral width different from the lateral width of the other adjustablebridge members.
 31. The occipito-cervical fixation system of claim 25,wherein the at least one rod coupling device comprises a pair of rodcoupling devices each including a laterally extending through openingthat extends in a lateral direction, and the one adjustable bridgemember includes a pair of laterally extending arms configured to bepivotally received in the laterally extending through openings.
 32. Theoccipito-cervical fixation system of claim 31, wherein the oneadjustable bridge member further includes an arched portioninterconnecting the laterally extending arms having a generally invertedU-shaped configuration for providing clearance for avoiding contact withthe spine.
 33. The occipito-cervical fixation system of claim 25,wherein the first adjustable connection includes a first lockingmechanism operable to fix the plate member and the one adjustable bridgemember against pivoting about the first lateral pivot axis, and thesecond adjustable connection includes a second locking mechanismindependently operable from the first locking mechanism to fix the oneadjustable bridge member and the at least one coupling device againstpivoting about the second lateral pivot axis.